A Phase 2 Study of LY2835219 for Patients With Previously Treated Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 27
- 主要终点
- Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
研究概览
简要总结
The main purpose of this study is to evaluate whether the study drug known as abemaciclib is effective in treating participants with breast cancer who have already tried other drug treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Have either a history of central nervous system (CNS) metastasis or evidence of CNS metastasis on the magnetic resonance image of brain obtained at baseline.
- •Received prior therapy with another cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor.
- •Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug.
- •Have had major surgery within 14 days of the initial dose of study drug.
- •Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix).
研究组 & 干预措施
Abemaciclib
200 milligrams (mg) abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
干预措施: Abemaciclib (Drug)
结局指标
主要结局
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
时间窗: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
次要结局
- Duration of Response (DOR)(From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 14 Months))
- Overall Survival (OS)(From Date of First Dose until Death Due to Any Cause (Up To 27 Months))
- Number of Participants With Categorical Change From Baseline in Brief Pain Inventory Short Form (mBPI-sf) - Worst Pain Score(Cycle 6 Day 1)
- Percentage of Participants With CR, PR or SD (Disease Control Rate [DCR])(From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months))
- Progression Free Survival (PFS)(From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 27 Months))
- Percentage of Participants With Tumor Response of Stable Disease (SD) for at Least 6 Months, Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate)(From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months))
- Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) for Abemaciclib and Metabolites M2 and M20(Cycle 1 Day 1 pre dose, Cycle 1 Day 15 4 hours (h) and 7 h post dose, Cycle 2 Day 1 pre dose and 3 h post dose, Cycle 3 Day1 pre dose)
- Number of Participants With Categorical Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status Score(Cycle 6 Day 1)